Smoking Cessation Trial Research Articles

I smoke to cope with pain: patients' perspectives on the link between cigarette smoking and pain.

For people with chronic pain, cigarette smoking is associated with greater pain intensity and impairment. Researchers have hypothesized areciprocal relationship in which pain and smoking exacerbate each other, resulting in greater pain and increased smoking. This study aimed to qualitatively examine patient perspectives on this association. Aretrospective thematic analysis of smoking cessation counseling notes for 136 veterans in the Pain and Smoking Study, atailored smoking cessation trial, was conducted. Avalidated codebook was applied to each counseling note by four independent coders using Atlas.ti (Atlas.ti, Berlin, Germany). Coders participated in aconsensus-forming exercise with salient themes validated among the wider research team. Participants averaged 60years of age (range 28-77years) and were 9% female. The median number of cigarettes smoked per day was15, with amean pain intensity score in the last week (from 0-10) of 5.1. While not all patients acknowledged aconnection between pain and smoking, we found that (1)pain motivates smoking and helps manage pain-related distress, as acoping strategy and through cognitive distraction, and (2)pain motivates smoking but smoking does not offer pain relief. Concerns about managing pain without smoking was identified as anotable barrier to cessation. Many patients with chronic pain who smoke readily identified pain as amotivator of their smoking behavior and are reluctant to quit for this reason. Integrated interventions for smokers with pain should address these perceptions and expectancies and promote uptake of more adaptive self-management strategies for pain.

Integrated Smoking Cessation for Smokers With Serious Mental Illness: Protocol for a Convergent Mixed Methods Implementation Evaluation Study.

BackgroundTobacco smoking is associated with significant morbidity and premature mortality in individuals with serious mental illness. A 2-year pragmatic clinical trial (PCORI PCS-1504-30472) that enrolled 1100 individuals with serious mental illness in the greater Boston area was conducted to test 2 interventions for tobacco cessation for individuals with serious mental illness: (1) academic detailing, which delivers education to primary care providers and highlights first-line pharmacotherapy for smoking cessation, and (2) provision of community health worker support to smoker participants. Implementing and scaling this intervention in other settings will require the systematic identification of barriers and facilitators, as well as the identification of relevant subgroups, effective and unique components, and setting-specific factors.ObjectiveThis protocol outlines the proposed mixed methods evaluation of the pragmatic clinical trial to (1) identify barriers and facilitators to effective implementation of the interventions, (2) examine group differences among primary care physicians, and (3) identify barriers that stakeholders such as clinical, payor, and policy leaders would anticipate to impact the implementation of effective components of the intervention.MethodsQualitative interviews will be conducted with all study community health workers and selected smoker participants, primary care providers, and other stakeholders. Measures of performance and engagement will guide purposive sampling. The Consolidated Framework for Implementation Research will guide qualitative data collection and analysis in accordance with the following framework approach: (1) familiarization, (2) identifying a thematic framework, (3) indexing, (4) charting, and (5) mapping and interpretation. Joint display analyses will be constructed to analyze and draw conclusions across the quantitative and qualitative data.ResultsThe 3-year cluster-randomized trial has concluded, and the analysis of primary outcomes is underway. Results from the pragmatic trial and this mixed methods implementation evaluation will be used to help disseminate, scale, and expand a systems intervention.ConclusionsThe results of this mixed methods implementation evaluation will inform strategies for dissemination and solutions to potential barriers to the implementation of interventions from a smoking cessation trial for individuals with serious mental illness.International Registered Report Identifier (IRRID)DERR1-10.2196/25390

History and Correlates of Smoking Cessation Behaviors Among Individuals With Current or Past Major Depressive Disorder Enrolled in a Smoking Cessation Trial.

Smoking among adults with major depressive disorder (MDD) is at least double that of the general US population. More effective smoking cessation interventions for depressed smokers may be facilitated through a better understanding of the smoking and depression-related characteristics of this population. We used baseline data from 300 participants enrolled in randomized clinical trial for smokers with current or past MDD. We described history of smoking cessation behaviors (ie, quit attempts, quit motivation, and cessation treatment utilization) and used multivariate regression to identify demographic and depression-related correlates of these behaviors. Sixty-eight percent of participants reported at least one quit attempt in the past year, nearly 51% reported motivation to quit in the subsequent 30 days, and 83% reported prior use of a nicotine replacement therapy. A greater readiness to quit smoking was associated with increased age (p = .04) and lower cigarettes per day (p = .01). Greater use of smoking cessation medication was associated with greater education and nicotine dependence, minority race, and greater use of complementary reinforcers (eg, activities associated with increased reinforcing value of smoking; p's < .05). These data indicate that smokers with current or past MDD are highly motivated to quit smoking and have a history of engaging in efforts to quit. Interventions to promote smoking cessation behaviors should address younger and lighter smokers, who may perceive less risk from tobacco use, and efforts to promote smoking cessation medications and counseling should address minority smokers who are engaging in complementary reinforcers. These data are inconsistent with the assumption that smokers with serious mental illness are not willing to quit smoking and suggest the need for studies that test behavioral interventions that address complementary reinforcers to treat tobacco use in this community.

Cigarette Smoking and Risk Perceptions During the COVID-19 Pandemic Reported by Recently Hospitalized Participants in a Smoking Cessation Trial.

BackgroundCigarette smoking is a risk factor for severe COVID-19 disease. Understanding smokers’ responses to the pandemic will help assess its public health impact and inform future public health and provider messages to smokers.ObjectiveTo assess risk perceptions and change in tobacco use among current and former smokers during the COVID-19 pandemic.DesignCross-sectional survey conducted in May–July 2020 (55% response rate)Participants694 current and former daily smokers (mean age 53, 40% male, 78% white) who had been hospitalized pre-COVID-19 and enrolled into a smoking cessation clinical trial at hospitals in Massachusetts, Pennsylvania, and Tennessee.Main MeasuresPerceived risk of COVID-19 due to tobacco use; changes in tobacco consumption and interest in quitting tobacco use; self-reported quitting and relapse since January 2020.Key Results68% (95% CI, 65–72%) of respondents believed that smoking increases the risk of contracting COVID-19 or having a more severe case. In adjusted analyses, perceived risk was higher in Massachusetts where COVID-19 had already surged than in Pennsylvania and Tennessee which were pre-surge during survey administration (AOR 1.56, 95% CI, 1.07–2.28). Higher perceived COVID-19 risk was associated with increased interest in quitting smoking (AOR 1.72, 95% CI 1.01–2.92). During the pandemic, 32% (95% CI, 27–37%) of smokers increased, 37% (95% CI, 33–42%) decreased, and 31% (95% CI, 26–35%) did not change their cigarette consumption. Increased smoking was associated with higher perceived stress (AOR 1.49, 95% CI 1.16–1.91). Overall, 11% (95% CI, 8–14%) of respondents who smoked in January 2020 (pre-COVID-19) had quit smoking at survey (mean, 6 months later) while 28% (95% CI, 22–34%) of former smokers relapsed. Higher perceived COVID-19 risk was associated with higher odds of quitting and lower odds of relapse.ConclusionsMost smokers believed that smoking increased COVID-19 risk. Smokers’ responses to the pandemic varied, with increased smoking related to stress and increased quitting associated with perceived COVID-19 vulnerability.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-06913-3.

Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration.

Increased rates of smoking cessation will be essential to maximize the population benefit of low-dose CT screening for lung cancer. The NCI's Smoking Cessation at Lung Examination (SCALE) Collaboration includes eight randomized trials, each assessing evidence-based interventions among smokers undergoing lung cancer screening (LCS). We examined predictors of trial enrollment to improve future outreach efforts for cessation interventions offered to older smokers in this and other clinical settings. We included the six SCALE trials that randomized individual participants. We assessed demographics, intervention modalities, LCS site and trial administration characteristics, and reasons for declining. Of 6285 trial- and LCS-eligible individuals, 3897 (62%) declined and 2388 (38%) enrolled. In multivariable logistic regression analyses, Blacks had higher enrollment rates (OR 1.5, 95% CI 1.2,1.8) compared to Whites. Compared to "NRT Only" trials, those approached for "NRT + prescription medication" trials had higher odds of enrollment (OR 6.1, 95% CI 4.7,7.9). Regarding enrollment methods, trials using "Phone + In Person" methods had higher odds of enrollment (OR 1.6, 95% CI 1.2,1.9) compared to trials using "Phone Only" methods. Some of the reasons for declining enrollment included "too busy" (36.6%), "not ready to quit" (8.2%), "not interested in research" (7.7%), and "not interested in the intervention offered" (6.2%). Enrolling smokers in cessation interventions in the LCS setting is a major priority that requires multiple enrollment and intervention modalities. Barriers to enrollment provide insights that can be addressed and applied to future cessation interventions to improve implementation in LCS and other clinical settings with older smokers. We explored enrollment rates and reasons for declining across six smoking cessation trials in the lung cancer screening setting. Offering multiple accrual methods and pharmacotherapy options predicted increased enrollment across trials. Enrollment rates were also greater among Blacks compared to Whites. The findings offer practical information for the implementation of cessation trials and interventions in the lung cancer screening context and other clinical settings, regarding intervention modalities that may be most appealing to older, long-term smokers.

A Qualitative Study of the Impact of COVID-19 on Smoking Behavior for Participants in a Post-Hospitalization Smoking Cessation Trial.

(1) Background: COVID-19 has substantially altered individual environments and behaviors. We aim to explore the impact of COVID-19 on the smoking behavior of individuals trying to quit tobacco. (2) Methods: This study presents a qualitative analysis of individual interviews focused on perceived impacts of the COVID-19 pandemic on tobacco use among 39 participants in the Helping HAND 4 (HH4) post-hospitalization smoking cessation trial (NCT03603496). (3) Results: Emergent impacts of COVID-19 included change in routine, isolation, employment changes, and financial challenges; these in turn were associated with boredom, altered cravings and triggers, and increased stress. The availability of effective coping mechanisms instead of smoking to deal with stress heavily influenced subsequent smoking behavior. These results were triangulated with the Transactional Model of Stress, providing a framework to elucidate connections between factors such as perceived control, self-efficacy, and dispositional coping style, and highlighting potential areas for intervention. (4) Conclusions: Results suggest that stress during the COVID-19 pandemic may undermine effective coping skills among individuals enrolled in a post-hospitalization smoking cessation trial. Strengthening effective coping skills (e.g., minimizing the use of tobacco as a default stress response) and increasing perceived control and self-efficacy are promising intervention targets.

Examining the effects of stress and psychological distress on smoking abstinence in cancer patients.

Cancer patients who smoke report more stress and psychological distress than patients who do not smoke. It is unclear how these emotional symptoms may modify smoking behavior in cancer patients. We examined the influence of a smoking cessation intervention for cancer patients on stress and distress, and the effects of these symptoms on smoking abstinence. Mixed-methods secondary analysis of data from the Smokefree Support Study, a two-site randomized controlled trial examining the efficacy of Intensive (IT; n=153) vs. Standard Treatment (ST; n=150) for smoking cessation in newly diagnosed cancer patients. Stress coping, perceived stress, distress, and anxiety were self-reported at baseline, 3, and 6months. Abstinence was biochemically-confirmed at 6months. A subset of patients (n=72) completed qualitative exit-interviews. Patients were on average, 58years old, 56% female, and smoked a median of 10 cigarettes/day. There were no significant treatment group×time interactions or main effects of treatment group on stress or distress measures (p's>0.05), however there were significant main effects of time suggesting symptom improvements on each measure in both study groups (p's<0.05). In adjusted logistic regression models, lower levels anxiety at 3months predicted confirmed smoking abstinence at 6months (p=.03). Qualitatively, at 6months, patients reported their stress and smoking were connected and that the cessation counseling was helpful. Cancer patients enrolled in a smoking cessation trial report decreases in stress, distress and anxiety over time, and anxiety symptoms may impact smoking cessation success at follow-up resulting in an important intervention target.

Predictors of attrition in a smoking cessation trial conducted in the lung cancer screening setting

SignificanceAlthough it is a requirement that tobacco treatment is offered to cigarette smokers undergoing low-dose computed tomographic lung cancer screening (LCS), not all smokers engage in treatment. To understand the barriers to tobacco treatment in this setting, we evaluated predictors of attrition in a smoking cessation trial among individuals undergoing LCS. MethodsPrior to LCS, 926 participants, 50–80 years old, completed the baseline (T0) phone assessment, including demographic, clinical, tobacco, and psychological characteristics.Following LCS and receipt of the results, participants completed the pre-randomization (T1) assessment. ResultsAt the T1 assessment, 735 (79%) participants were retained and 191 (21%) dropped out. In multivariable analyses, attrition was higher among those who: smoked >1 pack per day (OR = 1.44, CI 1.01, 2.06) or had undergone their first (vs. annual) LCS scan (OR = 1.70, CI 1.20, 2.42). Attrition was lower among those with: more education (associates (OR = 0.67, CI = 0.46, 0.98) or bachelor's degree (OR = 0.56, CI 0.35, 0.91) vs. high school/GED), some (vs. none/a little) worry about lung cancer (OR = 0.60, CI 0.39, 0.92), or a screening result that was benign (OR = 0.57, CI 0.39, 0.82) or probably benign (OR = 0.38, CI 0.16, 0.90) vs. negative. ConclusionsThis study illuminated several LCS-related factors that contributed to trial attrition. Increasing tobacco treatment in this setting will require targeted strategies for those who report little lung cancer worry, are undergoing their first LCS exam, and/or who have a negative LCS result. Addressing attrition and reducing barriers to tobacco treatment will increase the likelihood of cessation, thereby reducing the risk of developing lung cancer.

Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation

BackgroundThe pandemic of SARS-CoV-2, which causes COVID-19, has caused disruptions in ongoing clinical trials and is expected to accelerate interest in conducting research studies remotely.ObjectiveA quasi-experimental, mixed methods approach was used to examine the rates of visit completion as well as the opinions and experiences of participants enrolled in an ongoing clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or telephone conferencing due to the COVID-19 pandemic.MethodsFor quantitative comparisons, we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, COVID-19 cohort) to a comparable cohort of participants followed over a similar time period in the calendar years 2018 and 2019 (n=51, pre–COVID-19 cohort) to examine the rates of completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from in-person to remote visits.ResultsParticipants in the COVID-19 cohort completed an average of 83.6% of remote clinic visits (95% CI 73.1%-91.2%), which was not significantly different than the in-person completion rate of 89.8% in the pre–COVID-19 cohort. Participants in the COVID-19 cohort returned an average of 93.2% (95% CI 83.5%-98.1%) of saliva specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100% in the pre–COVID-19 cohort. Two broad themes emerged from the qualitative data: (1) the benefits of remote visits and (2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most participants expressed a willingness to engage in remote visits in the future.ConclusionsEven in the context of a rapid transition from in-person to remote visits necessitated by the COVID-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes may impact study outcomes.Trial RegistrationClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/study/NCT03262662

Written Advice Given by African American Smokers to Their Peers: Qualitative Study of Motivational Messages.

BackgroundAlthough African Americans have the lowest rates of smoking onset and progression to daily smoking, they are less likely to achieve long-term cessation. Interventions tailored to promote use of cessation resources in African American individuals who smoke are needed. In our past work, we demonstrated the effectiveness of a technology-assisted peer-written message intervention for increasing smoking cessation in non-Hispanic White smokers. In this formative study, we have adapted this intervention to be specific for African American smokers.ObjectiveWe aimed to report on the qualitative analysis of messages written by African American current and former smokers for their peers in response to hypothetical scenarios of smokers facing cessation challenges.MethodsWe recruited African American adult current and former smokers (n=41) via ResearchMatch between April 2017 and November 2017. We asked participants to write motivational messages for their peers in response to smoking-related hypothetical scenarios. We also collected data on sociodemographic factors and smoking characteristics. Thematic analysis was conducted to identify cessation strategies suggested by the study participants.ResultsAmong the study participants, 60% (25/41) were female. Additionally, more than half (23/41, 56%) were thinking about quitting, 29% (12/41) had set a quit date, and 27% (11/41) had used electronic cigarettes in the past 30 days. Themes derived from the qualitative analysis of peer-written messages were (1) behavioral strategies, (2) seeking help, (3) improvements in quality of life, (4) attitudes and expectations, and (5) mindfulness/religious or spiritual practices. Under the behavioral strategies theme, distraction strategies were the most frequently suggested strategies (referenced 84 times in the 318 messages), followed by use of evidence-based treatments/cessation strategies. Within the seeking help theme, subthemes included seeking help or support from family/friends or close social networks (referenced 56 times) and health care professionals (referenced 22 times). The most frequent subthemes that emerged from improvements in the quality of life theme included improving one’s health (referenced 22 times) and quality of life (referenced 21 times). Subthemes that emerged from the attitude and expectations theme included practicing positive self-talk (referenced 27 times), autonomy/independence from the smoking habit (referenced six times), and financial cost of smoking (referenced five times). The two subthemes that emerged from the mindfulness/religious or spiritual practices theme were use of self-awareness techniques (referenced 36 times) and religious or spiritual practices to cope (referenced 13 times).ConclusionsOur approach to adapt a prior peer-message intervention to African American smokers yielded a set of evidence-based messages that may be suitable for smokers at all phases of motivation to quit (ready to quit or not ready to quit). In future research, we plan to assess the impact of texting these messages to African American smokers in a smoking cessation trial.

A qualitative study exploring older smokers' attitudes and motivation toward quitting during the COVID-19 pandemic.

Older individuals who smoke are at increased risk of having severe outcomes from COVID-19, due to their long-term smoking and underlying health conditions. In this qualitative study, we explored the impact of COVID-19 on attitudes toward smoking and motivation to quit. Participants (N = 30) were enrolled in a larger ongoing randomized controlled smoking cessation trial conducted in the lung cancer screening setting. From March to May 2020, we assessed quantitative and qualitative responses to participants’ overall concern about COVID-19, changes in amount smoked, and motivation to reduce/quit smoking. Responses to the quantitative questions indicated that 64.3% of participants were extremely concerned with COVID-19, 20.7% reported reductions in amount smoked, and 37.9% reported increased motivation to quit. The qualitative responses, which were transcribed and coded using Consensual Qualitative Research guidelines, expanded upon these findings by providing the content of participants’ concerns, which included perceived risk of contracting COVID-19, the added stressors caused by COVID-19, and a variable impact on the amount smoked and motivation to quit. Although half of participants expressed extreme concern regarding COVID-19, fewer indicated increased motivation or reduced smoking. Qualitative themes suggested that the initial two months of the pandemic prompted some smokers to reduce or quit, but it exacerbated smoking triggers for others. Understanding how the pandemic continues to affect this vulnerable group will aid in adapting methods to support their efforts to stop smoking and remain abstinent.

Beyond Alkaloids: Novel Bioactive Natural Products From Lobelia Species.

In this work, we reviewed the progress in the phytochemical and biological investigations of bioactive components derived from medicinally valuable Lobelia species. In the last 60 years, Lobelia has garnered significant attention from the phytochemist from around the world, majorly due to the discovery of bioactive piperidine alkaloids (e.g., lobinaline and lobeline) in the early 1950s. Later, lobeline underwent clinical trials for several indications including the treatment of attention deficit hyperactivity disorder and a multicenter phase three trial for smoking cessation. Subsequently, several other alkaloids derived from different species of Lobelia were also investigated for their pharmacological characteristics. However, in the last few years, the research focus has started shifting to the characterization of the other novel chemical classes. The major shift has been noticed due to the structurally similar alkaloid components, which essentially share similar pharmacological, physicochemical, and toxicological profiles. In this review, we present an up-to-date overview of their progress with special attention to understanding the molecular mechanisms of the novel bioactive components.

Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial

BackgroundRates of smoking among those with serious mental illness (SMI) are two to three times higher than for the general population. Smoking is rarely addressed in mental health settings. Innovative outreach and treatment strategies are needed to address these disparities. The current study is a pilot study of the feasibility and acceptability of a chronic care model of tobacco cessation treatment implemented in outpatient psychiatry clinics.MethodsParticipants were recruited from two outpatient psychiatric clinics and randomly assigned to intervention (counseling and nicotine replacement for 8 weeks, plus ongoing proactive outreach calls inviting reengagement in treatment) or control (brief education and referral to the state quit line). Assessments were conducted at 8 weeks (end of initial treatment block) and 6 months (end of window for retreatment). Feasibility was assessed by enrollment rate, treatment engagement, and completion of follow-up assessments. Acceptability was assessed both quantitatively and qualitatively. Preliminary efficacy was assessed by 7-day and 30-day abstinence rates, rate of quit attempts, and cigarettes per day. Psychological health was measured to assess for changes related to treatment group or attempts to quit smoking.ResultsNineteen participants were randomized to intervention and 19 to control. Recruitment proved feasible, and high rates of treatment engagement (mean of 4.5 sessions completed in initial treatment block, 89.5% uptake of nicotine replacement) and retention (94.7% of follow-up assessments completed) were observed. Treatment acceptability was high. As anticipated, there were no significant differences in abstinence between groups, but results generally favored the intervention group, including bio-verified 7-day abstinence rates of 21.1% in intervention vs. 17.6% in control and self-reported 30-day abstinence rates of 16.1% in intervention vs. 5.1% in control at 8 weeks. Significantly more intervention participants made at least one quit attempt (94.7% vs 52.6%; OR = 16.20, 95% CI: 1.79–147.01). Cigarettes per day decreased significantly more in the intervention group at 8 weeks (b = − 13.19, SE = 4.88, p = .02).ConclusionsIt was feasible to recruit and retain SMI patients in a smoking cessation trial in the context of outpatient psychiatry. The novel chronic care model treatment was acceptable to patients and showed promise for efficacy. If efficacious, a chronic care model could be effective at reducing smoking among SMI patients.Trial registrationClinicalTrial.gov #: NCT03822416 (registered January 30th 2019).

COVID-19 Impact on Smokers Participating in Smoking Cessation Trials: The Experience of Nondaily Smokers Participating in a Smartphone App Study.

Objectives: To provide initial insight into how the COVID-19 pandemic could affect smoking behaviors and cessation efforts that were underway at its onset.Methods: An additional survey was added to follow-up assessments in an ongoing smoking cessation study for nondaily smokers: a measure of impact of COVID-19 and a subset of previously administered scales measuring smoking, emotional well-being, and alcohol use. Pre–post tests were conducted (84 ± 28 days apart).Results: Participants (81/100 of enrolled; 67% female, 75% white, 10% Hispanic, 37 ± 11 years old) reported experiencing changes regarding work (35% income reduction/loss; 35% remote work) and living situation (15% consolidated residences). Participants reported their motivation to quit smoking “slightly” increased after COVID-19 (p < 0.001), more so in those having achieved 30-day abstinence (p = 0.0045). Worry, fear, and a desire to support the greater good increased (ps < 0.05). Increases in motivation to quit correlated positively with prosocial and wellness changes. Data from pre- to post-COVID-19 onset showed decreases in emotional well-being (increased stress, negative affect, decreased coping, positive affect, all ps < 0.01), but not changes in smoking abstinence (p = 0.65), readiness to quit (p = 0.16), smoking frequency (p = 0.96), or cigarettes per day (p = 0.96). Heavy drinking decreased (p < 0.01). Trying e-cigarettes increased (p = 0.04).Conclusions: Nondaily smokers participating in a smoking cessation study during the COVID-19 pandemic reported worsened emotional well-being without effects on smoking outcomes and said their motivation to quit was slightly increased. Correlations of motivation to quit with prosocial and wellness changes suggest that targeting these constructs may be particularly helpful during a pandemic.

The Perceived Impact of COVID-19 among Treatment-Seeking Smokers: A Mixed Methods Approach.

The consequences of the COVID-19 pandemic on behavioral health, including tobacco use, are not fully known. The current study sought to measure the perceived impact of COVID-19 and the resulting stay-at-home orders in Philadelphia, Pennsylvania and Buffalo, New York on smokers enrolled in four smoking cessation trials between March 2020 and July 2020. The survey collected quantitative data regarding life changes due to COVID-19, health/exposure status, and the impact on their cessation attempt (e.g., motivation to quit, change in triggers). The questionnaire collected qualitative data to better understand how such changes could explain changes in smoking behavior. Of the 42 participants surveyed, approximately half indicated that COVID-19 changed their motivation and ability to quit or remain quit. Among those who reported that it was easier to quit following the stay-at-home orders (n = 24), most attributed this to concerns regarding the severity of COVID-19 among smokers. Among those who reported more difficulty quitting (n = 15), most attributed this to their increased stress due to the pandemic and the inability to access activities, places, or people that could help them manage triggers. Given public health warnings of continued surges in COVID-19, these data provide insight into who may benefit from further smoking cessation support should existing restrictions or new stay-at-home orders be enacted.

Using the Cigarette Purchase Task to examine the relative reinforcing value of cigarettes among mothers with versus without opioid dependence.

The Cigarette Purchase Task (CPT), in which participants estimate the number of cigarettes they would smoke across increasing cigarette prices, measures the relative reinforcing value of cigarettes. Although opioid-dependent individuals are particularly vulnerable to tobacco addiction, more research is needed to elucidate whether and to what extent their motivation to smoke differs from not-opioid-dependent smokers controlling for potential sociodemographic differences. Participants were 173 women (65 opioid-dependent) in an ongoing clinical trial for smoking cessation. Baseline CPT responses were compared between opioid-dependent and not-opioid-dependent women using five demand indices: Demand Intensity; Omax; Pmax; Breakpoint (BP); and α, and two latent factors: Amplitude and Persistence. Final regression models adjusted for sociodemographic characteristics differing between the two groups. Opioid-dependent women had greater demand Intensity (i.e., number of cigarettes they would smoke if they were free) than not-opioid dependent women in the adjusted model, F(1, 156) = 6.93, p = .016. No other demand indices differed significantly. Regarding latent factors, demand Amplitude (i.e., volumetric consumption), but not Persistence (i.e., price insensitivity), was greater for opioid-dependent women in the adjusted model, F(1, 146) = 4.04, p = .046. These results further demonstrate that the CPT is a highly sensitive task that can illuminate potentially important individual and population differences in the relative reinforcing value of smoking. Greater demand Intensity and Amplitude differentiated smokers with comorbid opioid dependence; thus, decreasing smoking prevalence among opioid-dependent populations may require policies and interventions that can decrease cigarette demand Intensity and Amplitude. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure.

Varenicline, a partial nicotinic agonist, is theorized to attenuate pre-quit smoking reinforcement and post-quit withdrawal and craving. However, the mechanisms of action have not been fully characterized, as most studies employ only retrospective self-report measures, hypothetical indices of reinforcing value, and/or nontreatment-seeking samples. The current research examined the impact of pre-quit varenicline (vs. placebo) on laboratory measures of smoking and food (vs. water) reinforcement and craving. Participants were 162 treatment-seeking smokers enrolled in a randomized controlled trial of smoking cessation ( clinicaltrials.gov ID: NCT03262662). Participants completed two laboratory sessions: a pre-treatment session, ~ 1 week prior to beginning varenicline or placebo, and an active treatment session, after ~ 3 weeks of treatment. At each session, participants completed a laboratory choice procedure; on each of 36 trials, a lit cigarette, food item, or cup of water was randomly presented. Participants reported level of craving and spent $0.01-0.25 to have a corresponding 5-95% chance to sample the cue. As predicted, spending was significantly higher on cigarette trials than water trials, and varenicline resulted in a greater between-session decline in spending on cigarette trials (but not water) than did placebo. Cigarette craving was enhanced in the presence of smoking cues compared to water, but neither average (tonic) cigarette craving nor cue-specific cigarette craving was significantly influenced by varenicline. Food spending and craving were generally unaffected by varenicline treatment. These laboratory data from treatment-seeking smokers provide the strongest evidence to date that varenicline selectively attenuates smoking reinforcement prior to quitting.

The Relationship of E-Cigarette Use to Tobacco Use Outcomes Among Young Adults Who Smoke and Use Alcohol.

E-cigarette use is increasing among young adults in the U.S. However, longitudinal research studies examining associations between e-cigarette use and combustible cigarette use among young adults are limited. This study assessed the relationship of e-cigarette use to smoking reduction and cessation among young adults. This is a secondary analysis of a randomized controlled social media-based smoking cessation trial comprising adults ages 18 to 25 who smoked cigarettes and engaged in heavy episodic drinking (N = 179). Over 12 months, participants reported past month e-cigarette use with nicotine or tetrahydrocannabinol, cigarette quantity in the past week, quit attempts, and cessation strategies including nicotine e-cigarettes. Longitudinal regression models estimated associations between e-cigarette use, smoking reduction, and 7-day abstinence. Past-month nicotine e-cigarette use prevalence ranged from 53.1% at baseline to 50.3% at 12 months. Over 70% of participants who reported past month nicotine e-cigarette use also smoked cigarettes (ie, dual use). Neither past month nicotine nor tetrahydrocannabinol e-cigarette use was associated with smoking reduction or cessation. However, use of nicotine e-cigarettes as a cessation strategy among participants attempting to quit (N = 137) was positively associated with abstinence (adjusted odds ratio = 2.47, 95% CI = 1.20-5.09) and ≥50% reduction in cigarettes per week from baseline (aOR = 2.36,95% CI = 1.08-5.18), relative to other strategies. Nicotine e-cigarettes were significantly associated with improved tobacco use outcomes when used as a cessation strategy, but not when used apart from trying to quit smoking. Dual use may not be an effective path to achieve smoking cessation.

The Effectiveness and Ethics of Incentives for Research Participation: Two Embedded Randomized Recruitment Trials

Background: Using financial incentives to improve research participation is controversial and variably regulated due to uncertainty regarding whether incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons. Methods: Patients were randomly assigned to incentives of $0, $200, or $500 for participating in a trial comparing smoking cessation interventions, and to $0, $100, or $300 for participating in a trial evaluating an ambulation intervention. Each incentive trial was powered to rule out interactions between incentive size and perceived research risk (undue inducement), and between incentive size and income (unjust inducement), on the primary outcome of consenting to the parent trial. Findings: Incentives significantly increased enrollment among 654 patients in the smoking cessation trial (adjusted odds ratio (OR) for each increase in incentive = 1.70, 95% confidence interval (CI) = 1.34 – 2.17; p < 0.001), but not among 642 patients in the ambulation trial (adjusted OR = 0.88, 95% CI = 0.64 – 1.22; p = 0.45). In both trials, undue and unjust inducement were ruled out (upper confidence limits of ORs for undue inducement = 1.15 and 0.99, both p < 0.001; upper confidence limits of ORs for unjust inducement = 1.21 and 1.26, p = 0.011 and p < 0.001, respectively). In both trials, larger incentives were associated with more time spent reviewing consent forms (both p < 0.005). Incentives were not associated with perceived research risks, trial understanding, perceptions of coercion, or therapeutic misconceptions in either trial. Interpretation: Financial incentives increased trial enrollment in one of two trials, and did not produce undue or unjust inducement or other unintended consequences in either trial. Trial Registration: ClinicalTrials.gov number, NCT02697799. Funding Statement: National Cancer Institute. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: Approved by IRBs at the University of Pennsylvania and Northwestern University, using a waiver of the requirement for informed consent. The trials were also guided by an Ethics Advisory Board and overseen by a Data and Safety Monitoring Board (DSMB).

The nonparametric Behrens-Fisher problem in partially complete clustered data.

In randomized trials or observational studies involving clustered units, the assumption of independence within clusters is not practical. Existing parametric or semiparametric methods assume specific dependence structures within a cluster. Furthermore, parametric model assumptions may not even be realistic when data are measured in a nonmetric scale as commonly happens, for example, in quality-of-life outcomes. In this paper, nonparametric effect-size measures for clustered data that allow meaningful and interpretable probabilistic comparisons of treatments or intervention programs will be introduced. The dependence among observations within a cluster can be arbitrary. Point estimators along with their asymptotic properties for computing confidence intervals and performing hypothesis test will be discussed. Small sample approximations that retain some of the optimal asymptotic behaviors will be presented. In our setup, some clusters may involve observations coming from both intervention groups (referred to as complete clusters), while others may contain observations from one group only (referred to as incomplete clusters). In deriving the asymptotic theories, we do not impose any relation in the rate of divergence of the numbers of complete and incomplete clusters. Simulations show favorable performance of the methods for arbitrary combinations of complete and incomplete clusters. The developed nonparametric methods are illustrated using data from a randomized trial of indoor wood smoke reduction to improve asthma symptoms and a cluster-randomized trial for smokingcessation.